Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

August 30, 2022 updated by: Kyowa Kirin Pharmaceutical Development Ltd

A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ≥ 6 Months to < 18 Years Receiving Treatment With Opioids

To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center, Oncology Institute
      • Petach Tikva, Israel, 49202
        • Schneider Children Medical Center
  • Norway
      • Bergen, Norway, 5021
        • Haukeland Universitetssykehus
      • Oslo, Norway, 0372
        • Oslo University Hospital - Rikshospitalet
      • Trondheim, Norway, 7006
        • St. Olavs Hospital
  • Spain
      • Barcelona, Spain, 08035
        • Pediatric Oncology Unit Hospital Vall d'Hebron
      • Madrid, Spain, 28046
        • Hospital Infantil Universitario Nino Jesus
      • Madrid, Spain, 28050
        • Hospital Universitario Madrid Sanchinarro
      • Madrid, Spain, 28660
        • Unidad de Hematología y Oncología Pediátrica - Hospital Universitario HM Monteprincipe
      • Murcia, Spain, 03191
        • Hospital Universitario Virgen de la Arrixaca
  • United Kingdom
      • Leeds, United Kingdom, LS1 3EX
        • The Leeds Teaching Hosptial NHS Trust
      • Liverpool, United Kingdom, L12 2AP
        • Alder Hey Children's Hospital
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham Children's Hospital
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main inclusion criteria, patient with:

  • malignant or non-malignant pain who are receiving or (are about to receive) acute or chronic treatment with opioids
  • newly diagnosed constatipation, with history of constipation treated with laxatives or expected to develop constipation after opioid treatment
  • ability to be present in the clinic for at least 10 hours following the first study drug for blood sampling and to return at 24 hours for blood sampling.

Main exclusion criteria:

  • Current acute or chronic use of methadone
  • History of an neoplasm or an ongoing gastrointestinal-related issue
  • Signs or symptoms of gastrointestinal obstruction
  • History of prolonged neutropenia or thrombocytopenia with clinical sequelae.
  • Patients currently receiving the first cycle of chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Age group: > = 12y to < 18y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Names:
  • Moventig
Experimental: Age group: > = 12y to < 18y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Names:
  • Moventig
Experimental: Age group: > = 6y to < 12y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Names:
  • Moventig
Experimental: Age group: > = 6y to < 12y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Names:
  • Moventig
Experimental: Age group: > = 6mo to < 6y - Lower dose
Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Names:
  • Moventig
Experimental: Age group: > = 6mo to < 6y - Higher dose
Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months.
Drug: Naloxegol
Opioid Antagonist
Other Names:
  • Moventig

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation
Time Frame: Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours
Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
To characterise the pharmacokinetics of naloxegol after multiple, once-daily, oral dosing in paediatric opioid induced constipation patients who continue participation beyond Day 1
Time Frame: Day 7 (minimum 3 days of naloxegol treatment): pre-dose and 4 hours post-dose
Day 7 (minimum 3 days of naloxegol treatment): pre-dose and 4 hours post-dose
Palatability of naloxegol liquid drug formulation
Time Frame: Day 1 and Day 2 after dose
Day 1 and Day 2 after dose
Ability of the patient to swallow the tablet
Time Frame: Day 1 and Day 2 after dose
Day 1 and Day 2 after dose
Clinical outcome measures by assessment of laxative use
Time Frame: From Day 1 until the End of treatment (26 week of study)
From Day 1 until the End of treatment (26 week of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Pharmaceutical Development Ltd

Investigators

  • Principal Investigator: Patrick Davies, Nottingham Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

March 28, 2014

First Posted (Estimate)

March 31, 2014

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3820C00016
  • UTN: U1111-1154-5575 (Other Identifier: World Health Organization)
  • 2013-003935-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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